FDA.reportPublic FDA data

Application 078969

Type
ANDA
Sponsor
NATCO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDETABLET;ORALEQ 1MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-735Granisetron HydrochlorideGranisetron HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-735Granisetron HydrochlorideGranisetron HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-735Granisetron HydrochlorideGranisetron HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-735Granisetron HydrochlorideGranisetron HydrochlorideBreckenridge Pharmaceutical, Inc.ANDACurrent
63850-0005Granisetron hydrochlorideGranisetron hydrochlorideNatco Pharma LimitedANDACurrent
67877-184Granisetron HydrochlorideGranisetron HydrochlorideAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53914ORIG2018-05-01